Biosyn - Monofilament Absorbable - Covidien LP

Duns Number:058614483

Device Description: Monofilament Absorbable Suture,GS-25,(5),D-Tach,5x Violet Strands

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More Product Details

Catalog Number

-

Brand Name

Biosyn

Version/Model Number

CM-30-M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K000037,K000037

Product Code Details

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Device Record Status

Public Device Record Key

834fb0d0-3c78-484b-bef9-8107cf0a91ad

Public Version Date

September 13, 2022

Public Version Number

8

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

20884523006077

Quantity per Package

12

Contains DI Package

10884523006070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40